FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
20953–20976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2020
UniSmile Clear Aligner System
K191837 · NXC
Vitang Technology, LLC
Dental · 204d
Cleared Jan 29, 2020
VITA VIONIC Bond
K191926 · EBI
Vita Zanhnfabrik H. Rauter GmbH Co.
Dental · 195d
Cleared Jan 29, 2020
Ezvena IPC, Ezvena SQS
K191937 · JOW
Eezcare Medical Corp
Cardiovascular · 194d
Cleared Jan 29, 2020
WVSM (Wireless Vital Signs Monitor) RWC + miniCap
K191989 · MWI
Athena Gtx
Cardiovascular · 188d
Cleared Jan 29, 2020
Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
K192585 · OAP
Pjm Worldwide, LLC D/B/A Phoenix...
General & Plastic Surgery · 132d
Cleared Jan 29, 2020
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
K193051 · LSR
DiaSorin, Inc.
Microbiology · 89d
Cleared Jan 29, 2020
Anatomical Shoulder System
K193099 · PHX
Zimmer GmbH
Orthopedic · 83d
Cleared Jan 29, 2020
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K193642 · QDK
Dexcom, Inc.
Chemistry · 30d
Cleared Jan 28, 2020
V-DENUPET
K192146 · MQH
Vitromed GmbH
Obstetrics & Gynecology · 173d
Cleared Jan 28, 2020
The NightBlocks Appliance
K192581 · LQZ
Advanced Facialdontics, LLC
Dental · 131d
Cleared Jan 28, 2020
Terason uSmart3200T Ultrasound System
K193510 · IYN
Teratech Corporation
Radiology · 41d
Cleared Jan 28, 2020
MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE...
K193637 · KPR
Compania Mexicana DE Radiologia Cgr,...
Radiology · 32d
Cleared Jan 27, 2020
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
K191715 · OCU
STERIS Corporation
Gastroenterology & Urology · 215d
Cleared Jan 27, 2020
CMOS Video Rhino-Laryngoscope SSU
K192090 · EOB
Karl Storz SE & CO. KG
Ear, Nose, Throat · 175d
Cleared Jan 27, 2020
Xenocor Articulating Xenoscope Laparoscope
K193315 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 59d
Cleared Jan 27, 2020
M.U.S.T. Pedicle Screw System
K193365 · NKB
Medacta International S.A.
Orthopedic · 54d
Cleared Jan 26, 2020
Emission Computed Tomography System
K193241 · KPS
Shanghai United Imaging Healthcare...
Radiology · 62d
Cleared Jan 26, 2020
THD Procto Software System
K193512 · IYO
Thd Spa
Radiology · 39d
Cleared Jan 25, 2020
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative...
K191186 · GYC
Ad-Tech Medical Instrument Corporation
Neurology · 267d
Cleared Jan 24, 2020
Cellvizio 100 Series System with Confocal Miniprobes
K191144 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 269d
Cleared Jan 24, 2020
Paratrooper Plantar Plate Repair System
K191227 · MBI
Paragon 28, Inc.
Orthopedic · 262d
Cleared Jan 24, 2020
CARESCAPE B450
K191249 · MHX
GE Healthcare Finland Oy
Cardiovascular · 260d
Cleared Jan 24, 2020
LCCS VC-S RF Cannula
K191293 · GXI
Lccs Products Limited
Neurology · 255d
Cleared Jan 24, 2020
KardiaMobile, KardiaStation
K191406 · DXH
AliveCor, Inc.
Cardiovascular · 241d